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Last Updated: December 11, 2024

Details for New Drug Application (NDA): 084588


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NDA 084588 describes AMINOPHYLLINE, which is a drug marketed by Abraxis Pharm, Am Regent, Elkins Sinn, Hospira, Intl Medication, King Pharms, Luitpold, Lyphomed, Pharma Serve Ny, Smith And Nephew, Teva Parenteral, Morton Grove, Roxane, Impax Labs, Tablicaps, Vale, Ani Pharms, Ascot, Barr, Chartwell Molecular, Duramed Pharms Barr, Halsey, Hikma Intl Pharms, Kv Pharm, Pal Pak, Panray, Purepac Pharm, Valeant Pharm Intl, Vangard, Vintage Pharms, Watson Labs, and Actavis Mid Atlantic, and is included in fifty-eight NDAs. It is available from four suppliers. Additional details are available on the AMINOPHYLLINE profile page.

The generic ingredient in AMINOPHYLLINE is aminophylline. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the aminophylline profile page.
Summary for 084588
Tradename:AMINOPHYLLINE
Applicant:Chartwell Molecular
Ingredient:aminophylline
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength200MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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